MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number	1387000
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected vitros tsh result and a non-reproducible, higher than expected vitros ft4 result was obtained from a sample from a single patient when tested on a vitros 5600 integrated system.Patient a tsh result of 0.259 miu/l versus the expected result of 2.21 miu/l patient a ft4 result of 2.52 ng/dl versus the expected result of 0.7 ng/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.Patient sample results were reported from the laboratory and treatment was both administered and delayed based on the reported results.However, ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers 2510230, 2513241, 2513241, 2513243, 2513245 and reportability assessment 601512.`1.
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, lower than expected vitros tsh result and a non-reproducible, higher than expected vitros ft4 result was obtained from a sample from a single patient when tested on a vitros 5600 integrated system.A definitive assignable cause for the discordant lower than expected vitros tsh result and higher than expected vitros ft4 result could not be determined with the information provided.A vitros tsh and ft4 performance issue is not a likely contributor to the event as the customer made no suggestion of any issues with the qc fluids processed at the customer site and no issues regarding accuracy or precision of the vitros assays were indicated by the customer.Furthermore, precision testing of the vitros 5600 integrated systems was not performed, therefore it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample although this could not be confirmed.Furthermore, a sample specific interferent cannot be ruled out as the cause of the discordant vitros tsh and vitros ft4 results obtained for patient a.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with any of the vitros products associated with this issue.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16709454
• Report Number: 3007111389-2023-00057
• Device Sequence Number: 6080004
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: 1387000
• Device Catalogue Number: 1387000
• Device Lot Number: 5090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown